Fecal Calprotectin Test Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Assay Type (Enzyme Linked Immunosorbent Assay (ELISA), Enzyme Fluoroimmunoassay, and Quantitative Immune-Chromatography), By Indication (Inflammatory Bowel Disease (IBD) Diagnosis, Colorectal Cancer, Celiac Disease, and others), By End User (Hospitals, Diagnostic Laboratories, Academic and Research Institutes, and others), By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 353.10 Million
CAGR (2026-2031)	7.01%
Fastest Growing Segment	Inflammatory Bowel Disease (IBD)
Largest Market	North America
Market Size (2031)	USD 530.21 Million

Market Overview

The Global Fecal Calprotectin Test Market will grow from USD 353.10 Million in 2025 to USD 530.21 Million by 2031 at a 7.01% CAGR. The Global Fecal Calprotectin Test Market focuses on a non-invasive diagnostic immunoassay that quantifies calprotectin, a neutrophilic protein found in stool, to detect intestinal inflammation. This testing method is primarily utilized to differentiate between Inflammatory Bowel Disease (IBD) and functional gastrointestinal disorders such as Irritable Bowel Syndrome (IBS). The market is fundamentally driven by the rising prevalence of IBD and a clinical shift toward minimizing unnecessary invasive procedures, such as colonoscopies, which enhances patient compliance and healthcare cost-efficiency. According to Crohn's and Colitis Canada, in 2025, the prevalence of Inflammatory Bowel Disease is projected to reach 0.8% of the Canadian population, underscoring the expanding patient pool that requires regular, reliable disease monitoring.

However, a significant challenge impeding broader market expansion is the lack of assay standardization among various commercial manufacturers. Discrepancies in cut-off values and analytical performance across different test kits can lead to inconsistent results, which complicates the interpretation of data for clinicians and hinders the establishment of universal reference ranges necessary for long-term patient management. This variability creates hesitation regarding the interchangeability of results, potentially delaying the adoption of these tests as the sole standard for disease monitoring.

Key Market Drivers

The increasing global incidence of Inflammatory Bowel Diseases (IBD) serves as a primary catalyst for the expansion of the Global Fecal Calprotectin Test Market. As chronic conditions such as Crohn's disease and ulcerative colitis become more prevalent, the demand for reliable, non-invasive monitoring tools has surged to manage long-term inflammation and prevent relapse effectively. According to the Centers for Disease Control and Prevention, June 2024, in the 'IBD Facts and Stats' report, the prevalence of IBD in the United States was estimated to be between 2.4 and 3.1 million individuals. This expanding patient pool necessitates frequent testing to distinguish between active inflammation and functional disorders, thereby driving the consumption of calprotectin assays. The market's trajectory is further corroborated by significant patient numbers internationally; according to Crohn's & Colitis UK, in 2024, approximately 500,000 people were reported to be living with IBD across the United Kingdom, underscoring the critical need for scalable diagnostic solutions in developed healthcare systems.

Simultaneously, technological innovations in point-of-care and home-testing kits are reshaping market dynamics by enhancing patient convenience and sample stability. Historically, the logistical challenges of preserving fecal samples during transport limited the adoption of remote monitoring, but recent advancements in buffer stability have mitigated these barriers. According to Sentinel Diagnostics, November 2024, in the 'Sentinel Diagnostics Presents Latest Breakthroughs in Diagnostics' announcement, the company highlighted the capabilities of its new CALiaGold pierce Tube, which allows patients to store samples at room temperature for up to four weeks before analysis. Such innovations significantly improve patient compliance by simplifying the collection process, allowing for more consistent disease monitoring outside of clinical settings. This shift toward user-friendly, robust home-testing solutions is expected to accelerate market penetration, particularly for patients requiring lifelong disease management.

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Key Market Challenges

The lack of assay standardization among commercial manufacturers acts as a significant barrier to the growth of the Global Fecal Calprotectin Test Market. Since different test kits often utilize varying antibodies and capture methods, they frequently produce inconsistent quantitative results and cut-off values for identical patient samples. This analytical variability complicates clinical interpretation, making it difficult for healthcare providers to establish universal reference ranges or compare data across different testing platforms. Consequently, clinicians remain hesitant to rely solely on these immunoassays for longitudinal patient monitoring, which restricts the widespread adoption of this diagnostic tool in routine medical practice.

This inconsistency directly impedes market scalability, particularly given the urgent demand for reliable chronic disease management. According to the Crohn's & Colitis Foundation, in 2024, approximately 3 million Americans were estimated to be affected by Inflammatory Bowel Disease. With such a substantial patient population requiring frequent inflammation monitoring, the inability to interchange results between different manufacturers creates a operational bottleneck. Healthcare systems are unlikely to fully commit to a testing modality where data cannot be harmonized across laboratories, thereby limiting the overall revenue potential and market penetration of these diagnostic products.

Key Market Trends

The Shift Toward Automated High-Throughput Laboratory Immunoassays is transforming the market as clinical laboratories transition from manual methods to integrated platforms to handle escalating sample volumes. Traditional Enzyme-Linked Immunosorbent Assays (ELISA) are increasingly being replaced by particle-enhanced turbidimetric immunoassays (PETIA) that run on standard clinical chemistry analyzers, enabling random-access testing and drastically reducing turnaround times. This automation allows diagnostic facilities to scale operations efficiently, a critical capability given the rising demand for gastrointestinal testing. Underscoring this advancement, according to Sysmex America, January 2025, in the 'Sysmex America Signs Agreement to Distribute and Service Sentinel Diagnostics SENTiFIT® in Canada' announcement, the company secured rights to distribute the SENTiFIT 800 Analyzer, a high-speed system capable of processing up to 550 tests per hour, thereby facilitating mass-volume analysis for laboratories managing high testing workloads.

Simultaneously, the market is experiencing Increasing Utilization for Longitudinal Treatment Monitoring and Mucosal Healing, moving beyond the test’s initial role in differentiating IBD from IBS. Clinicians are adopting "treat-to-target" strategies that rely on frequent fecal calprotectin measurement as a non-invasive surrogate for endoscopy to assess mucosal inflammation and therapeutic response in established patients. This clinical shift is further validated by evolving reimbursement structures designed to support regular disease tracking and prevent relapses. Highlighting this regulatory support, according to The Limbic, October 2025, in the 'IBD patients to get new subsidised faecal calprotectin test' article, the Australian government introduced a new Medicare item number specifically to subsidize calprotectin testing for the ongoing management of symptomatic patients with an established IBD diagnosis, reflecting a global recognition of the test's value in long-term care.

Segmental Insights

The Inflammatory Bowel Disease segment represents the fastest expanding category within the Global Fecal Calprotectin Test Market due to the rising clinical demand for non-invasive diagnostic tools. Healthcare providers increasingly utilize these tests to differentiate between Inflammatory Bowel Disease and functional disorders like Irritable Bowel Syndrome, thereby reducing the necessity for invasive endoscopy procedures. This adoption is further supported by recommendations from organizations such as the National Institute for Health and Care Excellence, which advocate for fecal calprotectin testing to streamline patient management and improve diagnostic accuracy.

Regional Insights

North America leads the global fecal calprotectin test market due to the rising prevalence of inflammatory bowel diseases and a strong emphasis on early diagnosis. The region benefits from established healthcare systems that support regular screening for gastrointestinal disorders. Furthermore, the U.S. Food and Drug Administration facilitates market growth through clear regulatory pathways for diagnostic product approvals. The concentration of major diagnostic manufacturers in the United States and Canada also ensures high product availability, allowing healthcare providers to adopt these testing methods effectively within clinical settings.

Recent Developments

• In March 2025, Gentian Diagnostics announced a strategic partnership with Beckman Coulter Diagnostics to launch the GCAL Calprotectin Immunoassay on Beckman Coulter's clinical chemistry platforms. This collaboration aimed to expand the availability of the open-channel, particle-enhanced turbidimetric immunoassay, making it accessible to a broader network of laboratories using high-throughput automated analyzers. The launch focused on providing a cost-effective and efficient solution for inflammation assessment, leveraging the established market reach of the partner to drive the adoption of calprotectin testing in routine clinical practice.
• In November 2024, Sentinel Diagnostics showcased its CALiaGold quantitative latex immunoassay during the MEDICA 2024 international trade fair. The company highlighted the assay's ability to accurately measure fecal calprotectin as a marker for intestinal inflammation when used in conjunction with its automated analyzer systems. This presentation focused on the diagnostic system's utility in differentiating between Inflammatory Bowel Disease (IBD) and Irritable Bowel Syndrome (IBS), emphasizing the solution's integration into high-throughput laboratory workflows to enhance screening efficiency for colorectal conditions.
• In July 2024, Eurofins Scientific expanded its diagnostic capabilities by launching onsite stool calprotectin testing at its facility in Dublin, Ireland. This development marked a significant enhancement in the company's local service offerings, allowing for faster turnaround times for patients and healthcare providers in the region. By performing the test locally rather than outsourcing it, the company aimed to improve the efficiency of distinguishing between organic inflammatory conditions and functional bowel disorders, thereby supporting quicker clinical decision-making for gastrointestinal health.
• In February 2024, BÜHLMANN Laboratories AG received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its fCAL turbo assay and CALEX Cap stool preparation device. This regulatory approval authorized the use of the particle-enhanced turbidimetric immunoassay (PETIA) on clinical chemistry analyzers in the United States, allowing for the quantitative measurement of fecal calprotectin in human stool. The clearance facilitated the automation of calprotectin testing in clinical laboratories, streamlining the workflow for diagnosing inflammatory bowel disease (IBD) and differentiating it from irritable bowel syndrome (IBS).

Key Market Players

• Thermo Fisher Scientific Inc.
• Bio-Rad Laboratories, Inc.
• F. Hoffmann-La Roche Ltd
• Boditech Med Inc.
• Abbexa Ltd.
• Elabscience Bionovation Inc.
• Epitope Diagnostics, Inc.
• R-Biopharm AG
• Sentinel Ch S.p.A.
• LifeSpan BioSciences, Inc

By Assay Type	By Indication	By End User	By Region
Enzyme Linked Immunosorbent Assay (ELISA) Enzyme Fluoroimmunoassay and Quantitative Immune-Chromatography	Inflammatory Bowel Disease (IBD) Diagnosis Colorectal Cancer Celiac Disease and others	Hospitals Diagnostic Laboratories Academic and Research Institutes and others	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Fecal Calprotectin Test Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Fecal Calprotectin Test Market, By Assay Type:

• Enzyme Linked Immunosorbent Assay (ELISA)
• Enzyme Fluoroimmunoassay
• and Quantitative Immune-Chromatography

• Fecal Calprotectin Test Market, By Indication:

• Inflammatory Bowel Disease (IBD) Diagnosis
• Colorectal Cancer
• Celiac Disease
• and others

• Fecal Calprotectin Test Market, By End User:

• Hospitals
• Diagnostic Laboratories
• Academic and Research Institutes
• and others

• Fecal Calprotectin Test Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE